HypercholesterolemiaNCT06247137
Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation
A study testing Dietary Supplement in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
Trial summary
Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol blood levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
- Patient covered by the Social Security scheme.
Who cannot join
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
- Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
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- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- Abuse of alcohol or drugs (current or previous);
- History of malignant neoplasia in the 5 years prior to enrolment in the study;
- History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- Known previous intolerance to one component of the tested nutraceuticals
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial
Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention.
Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and / or pharmacological habits to perform an effective cardiovascular prevention.
Read more
Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium, recent studies suggest that the activation of a low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk factors, does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries. It is believed that this systemic inflammation, as documented by the determination of some humoral signs of inflammation (e.g. C-reactive protein, interleukin-6, tumor necrosis factor-α), may further contribute to an increase of cardiovascular risk.
The inflammatory state can modulate the atherosclerotic process at various levels, determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells; the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.
- Conditions
- Hypercholesterolemia
- Being tested
- Dietary Supplement, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients.
Oral administration: 1 tablet/day at evening meal
PlaceboOther
Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides).
Oral administration: 1 tablet/day at evening meal.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Active comparator | Not described Receives: Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterolemia reduction from baseline and between groups
Reduction of LDL-cholesterolemia after 3 months of treatment
Measured: 3 months
Secondary outcomes (3)
LDL-cholesterolemia reduction from baseline and between groups at 6 weeks
Reduction of LDL-cholesterolemia after 6 weeks of treatment
Measured: 6 weeks
Changes in hsCRP
Evaluate the effect of the dietary supplementation on blood levels of hsCRP after 3 months of treatment
Measured: 3 months
Change in vascular reactivity
Evaluate the effect of the dietray supplementation on the vascular reactivity (Endocheck®)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Apr 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, MD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247137
- Sponsor's protocol ID
- NUT1-BO-2021
- Status last verified
- Apr 2024
- First submitted
- 30 Jan 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT06247137
- Acronym / sponsor ID
- NUT1-BO-2021
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention.
Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and / or pharmacological habits to perform an effective cardiovascular prevention.
Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium, recent studies suggest that the activation of a low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk factors, does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries. It is believed that this systemic inflammation, as documented by the determination of some humoral signs of inflammation (e.g. C-reactive protein, interleukin-6, tumor necrosis factor-α), may further contribute to an increase of cardiovascular risk.
The inflammatory state can modulate the atherosclerotic process at various levels, determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells; the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol blood levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
Key exclusion criteria (15 listed)
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary SupplementDietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients. Oral administration: 1 tablet/day at evening meal | Dietary supplement | Dietary supplement |
| PlaceboPlacebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides). Oral administration: 1 tablet/day at evening meal. | Other | Placebo |
Primary outcome
LDL-cholesterolemia reduction from baseline and between groups
Time frame: 3 months
Reduction of LDL-cholesterolemia after 3 months of treatment
3 secondary outcomes
LDL-cholesterolemia reduction from baseline and between groups at 6 weeks
Time frame: 6 weeks
Changes in hsCRP
Time frame: 3 months
Change in vascular reactivity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Borghi, MD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-cholesterolemia reduction from baseline and between groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.